Pharma major, Lupin Ltd announced today that it has received official communication from the US FDA on the satisfactory resolution of the Warning Letter issued earlier to its Mandideep site. The company had received a Warning letter for its Mandideep site in May 2009. In the ensuing seven months, the company made significant enhancements and took appropriate corrective actions. The facility was re-inspected in November 2009 and the company was able to satisfactorily address all of the concerns related to the Warning Letter and the site compliance status was found to be acceptable.
In the last quarter, the FDA inspected two new sites of the company at Aurangabad (liquids) & Indore (oral solids and oral contraceptives). Aurangabad was found acceptable with no 483’s and Indore was found acceptable with one 483 observation which was satisfactorily addressed before the close of the inspection. These recent successful inspections bring the company a step closer to launching liquids and oral contraceptives.
Earlier, the UK MHRA and the Australian TGA had also conducted a joint inspection of the Mandideep facility and had found it acceptable.
Speaking of the inspections, Nilesh Gupta, Group President and Executive Director, said "We are very pleased that we have been able to satisfactorily address the US FDA's concerns and clear the status of Mandideep. We are very proud that our people have been able to make this happen. This achievement is even more commendable in the current heightened regulatory environment and is strong testimony of how we are moving up the regulatory curve. With the recent inspections and satisfactory resolution of all pending concerns at Mandideep, all our facilities have now been inspected in the past year and have been found to be in good shape".